Hypersomnia in the Paediatric Population
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversity Hospital, Montpellier
About this trial
This is a 36-month, multicentric, cross-sectional study involving a paediatric population aged 6 to 17 years. Three groups will be included:
Group A: children from the general population with no complaints of sleepiness; Group B: children with a sleep disorder or excessive sleepiness associated with a medical condition (narcolepsy, circadian rhythm sleep disorder (CRSD), non-REM parasomnias, attention deficit disorder with or without hyperactivity (ADHD), autism spectrum disorder (ASD) or obesity); Group C: healthy volunteers with no medical conditions or sleep-related complaints.
Eligibility criteria
Qualifiers
Be aged between 6 and 17 (< 18 years old).
Be able to express consent to participate.
Have at least one legal guardian.
Speak and understand French.
Disqualifiers
Souhait du mineur d'interrompre l'étude.
Maladie ou condition intercurrente qui interfère avec la poursuite de la participation du sujet à l'étude.
Lors de la visite 2 : si traitement médicamenteux qui agit sur la somnolence ou la vigilance, ou qui n'a pas été stoppé suffisamment tôt.
Décision de l'investigateur.
Trial design
Treatments tested in this trial
- Sleepness and wakeness scale
- Polysomnography
- Actimetry
- Diagnostic scales
- Ambulatory blood pressure monitoring (ABPM)
- blood sampling
- Urine collection
Treatment groups
760 Participants
are divided into 3 treatment groupsSponsors and collaborators
University Hospital, Montpellier
Lead sponsor
Société Française de Recherche et de Médecine du Sommeil
Collaborator
Source ClinicalTrials.gov